The Drug Approval Process. An Overview

AuthorKenneth L. Dorsney
chapter 2
The Drug Approval
Process—An Overview
A drug sponsor must obtain the Food and Drug Administration’s (FDA)
approval of a new drug application (NDA) prior to marketing a new phar-
maceutical1 in the United States.2 To obtain FDA approval of an NDA, the
Food, Drug, and Cosmetic Act (FDCA) requires the drug sponsor to dem-
onstrate that the “methods used to manufacture the drug ‘are adequate
to preserve the drug’s identity, strength, quality, and purity’” and that
the labeling on the drug packaging is appropriate.3 Most importantly,
however, the FDCA requires the drug sponsor to set forth “substantial
evidence” that demonstrates that the drug is “effective and safe”4 for its
“intended use(s).”5 The FDCA defines “substantial evidence” as “evidence
consisting of adequate and well-controlled investigations . . . by experts
qualified by scientific training and experience to evaluate the effectiveness
of the drug involved.”6 The NDA approval process can be broken down into
(1) pre-NDA-filing activities; and (2) NDA-filing and postfiling activities.
Karen E. Keller, Shaw Keller LLP (author, first and second editions), and Gregory J.
Brodzik, Young Conaway Stargatt & Taylor LLP (author, first edition).
1. In practice, a pharmaceutical that is approved under an NDA is referred to as a
“brand” drug. Esther H. Steinhauer, Is Noerr-Pennington Immunity Still a Viable Defense
against Antitrust Claims Arising from Hatch-Waxman Litigation?, 61
FOOD & DRUG L.J. 679,
680 (2006).
2. See 21 U.S.C. § 355(b)(1) (2012).
3. Brian Porter, Stopping the Practice of Authorized Generics: Mylan’s Effort to Close
the Gaping Black Hole in the Hatch-Waxman Act, 22
178 (2005); see 21 U.S.C. § 355(d) (2012). The Food, Drug, and Cosmetics Act regulates the
marketing of “drugs,” defined as items that are “intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other animals.” 21 U.S.C. § 321(g)
(1) (2012).
4. Laba Karki, Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman
Act, Regulatory Amendments and Implications for Drug Patent Enforcement, 87
J. PAT. &
TRADEMARK OFF. SOCY 602, 605 (2005);
see 21 U.S.C. § 355(d).
5. Carolyne R. Hathaway et al., Looking Abroad: Clinical Drug Trials, 63
L.J. 673, 675 (2008); see 21 U.S.C. § 355(d).
6. 21 U.S.C. § 355(d).
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